Recall Z-1068-2008 ยท BZD Ventilator, Non-Continuous (Respirator)
Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model number DS200H; d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS; e) REMStar Plus M w/Smartcard, US model number DS200S; and f) REMStar Plus w/C Flex Dom model number 1009586. Filter,
| Date | Apr 24, 2008 (initiated Oct 15, 2007) |
| Status | Terminated |
| Reason | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Root cause | Environmental control |
| Action | The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent. |
| Quantity | 20950 units |
| Distribution | The products were shipped nationwide to medical facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052110 | M-SERIES PRO CPAP SYTEM Respironics, Inc., Oct 20, 2005 |